Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read.
The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you change your mind. Listen to Stefan Bolleininger who will explain to you how your customers can get reimbursed.
The post How to get your Digital Health Application reimbursed in Germany? (DIGA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to get your Digital Health Application reimbursed in Germany? (DIGA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy!
The post Medical Device News – April 2020 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News – April 2020 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Don't worry, we will not show you any equation for calculating the sample size. But we will show you how to do it and why you should be careful on some important parameters. Then you can see some examples in the ebook provided by Jon.
The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
This week there was an important vote regarding the proposal to delay the EU MDR until May 26, 2021. The parliament adopted it and we wait for the publication on the official journal. But what will be the consequence for Medical Device Manufacturers, Notified Bodies...
The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequences. And they try then to find other ways. Let's explore them with Karandeep Badwal
The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Did you know that the EU MDR is amending 2001/83/EC for Medicinal Products. This may have some consequences for your products if it involves a Drug-Device combination. Monir El Azzouzi and Theresa Jeary are explaining to you what should be done.
The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
The month of March 2020 is over but there was a lot of information provided regarding the Medical Device industry so let's listen to the different news with Monir El Azzouzi
The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
This is an important question if you understand the rule for a transition period of your device under EU MDR article 120(3). If you perform a significant change then you may be prepared for the consequences. Let's see what are the advice of Erik Vollebregt if you reach this situation.
The post What is a Significant Change for your Medical Device? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post What is a Significant Change for your Medical Device? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
In this episode we will focus specifically on Medical Device class I that are "Sterile", with measuring function" or "Reusable surgical instruments". Elem Ayne will help us to understand what you should prepare to be compliant.
The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Do you recall those movies with hackers that are taking the control of an hospital or of your pacemaker. Is this Science Fiction or reality. On this episode, Monir and Erik will explain to you how to secure your medical devices if they are connected to a network.
The post Cybersecurity for your Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Cybersecurity for your Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
In this episode, we will talk about, Coronavirus, MDCG, Notified Body, US guidance, Podcast episodes, LinkedIn Live... So don't miss it.
The post Medical Device Regulatory Update – February 2020 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device Regulatory Update – February 2020 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on this episode where Erik Vollebregt will help us understand the requirements of the regulation.
The post Do your Economic Operators need a Quality Management System? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Do your Economic Operators need a Quality Management System? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
The intended purpose of your device is critical but a lot of manufacturers are nor really putting much effort to write a good one. Check on this episode with Cesare Magri why this is important and how to create it correctly.
The post Create your intended purpose with Cesare Magri (Medical Device) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Create your intended purpose with Cesare Magri (Medical Device) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Your Economic Operators do have some responsibility per EU MDR and IVDR. What should they check? Monir El Azzouzi and Erik Vollebregt will help you understand that on this bonus episode.
The post Medical Device School: What should verify your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device School: What should verify your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
